K082640 is an FDA 510(k) clearance for the VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, a Mesh, Surgical, For Stress Urinary Incontinence, Male (Class II — Special Controls, product code OTM), submitted by Coloplast Manufacturing Us, LLC (Minneapolis, US). The FDA issued a Cleared decision on October 17, 2008, 37 days after receiving the submission on September 10, 2008. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K082640 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 10, 2008 |
| Decision Date | October 17, 2008 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | OTM — Mesh, Surgical, For Stress Urinary Incontinence, Male |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.3300 |
| Definition | Surgical Treatment Of Male Stress Urinary Incontinence Post-prostatectomy |